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A Phase 3, Randomized, Active-Controlled, Double-Blind, Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-004772-21

A Phase 3, Randomized, Active-Controlled, Double-Blind, Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Spain. - Estudio fase III, randomizado, controlado, doble ciego para evaluar la seguridad, tolerabilidad e inmunogenicidad de la Vacuna Neumocócica Conjugada 13-valente en niños sanos administrada según calendario vacunal en España

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Extrait

Primary objectives· - To demonstrate that the immune response induced by Meningitec given with 13vPnC is noninferior to the immune response induced by Meningitec given with 7vPnC when measured 1 month after the 2-dose Meningitec infant series. - To demonstrate that the immune responses induced by Infanrix hexa given with 13vPnC are noninferior to the immune responses induced by Infanrix hexa given with 7vPnC when measured 1 month after the 3-dose infant series. Safety objective·- To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local injection site reactions, systemic events, and adverse events (AEs). 13vPnC Immunogenicity objectives·- To assess the immune responses to 13vPnC 1 month after the second dose and 1 month after the third dose of a 3-dose infant series as measured by serum immunoglobulin G (IgG) responses. - To assess the immune responses to 13vPnC 1 month after the toddler dose as measured by serum IgG responses.

Critère d'inclusion

  • Healthy infants - Niños sanos

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